NCT05966168

Brief Summary

The purpose of this study is to determine the effectiveness of the Micra AV 2.0 device during exercise or elevated heart rates. Participation in research studies is voluntary. In this study, participants will already be planned to have a Micra AV 2.0 device implanted. Participants will then undergo treadmill exercise testing and wear a Holter monitor. For each participant, the tracking performance of the Micra AV 2.0 will be evaluated at rest and during exercise. Follow up visits will occur as part of standard of care and each participant will be enrolled in the study for up to 6 months.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1.5 years

First QC Date

July 21, 2023

Last Update Submit

April 16, 2024

Conditions

Heart Block AV

Keywords

AV Heart BlockHigh-grade Heart BlockMICRA AVMedtronic

Outcome Measures

Primary Outcomes (3)

  • Average tracking index at rest

    Calculated as the percentage of atrial mechanically sensed, ventricular paced event (AM-VP) divided by total VP percentage.

    6 months

  • Average tracking index during exercise

    Calculated as the percentage of atrial mechanically sensed, ventricular paced event (AM-VP) divided by total VP percentage.

    6 months

  • Average tracking index during recovery

    Calculated as the percentage of atrial mechanically sensed, ventricular paced event (AM-VP) divided by total VP percentage.

    6 months

Secondary Outcomes (9)

  • Average total AV synchrony at rest

    6 months

  • Average total AV synchrony during exercise

    6 months

  • Average total AV synchrony during recovery

    6 months

  • Average tracking index

    6 months

  • Average total AV synchrony

    6 months

  • +4 more secondary outcomes

Study Arms (1)

Micra AV Exercise Testing

EXPERIMENTAL

All participants will have Micra AV 2.0 implanted then undergo exercise testing while wearing Holter Monitor

Device: Medtronic Micra AV Device

Interventions

Medtronic Micra AV DeviceDEVICE

Participants will already be planned to have a Micra AV 2.0 device implanted. Participants will then undergo treadmill exercise testing and wear a Holter monitor to determine the effectiveness of the Micra AV 2.0 device during exercise or elevated heart rates.

Also known as: Micra AV Tracking During Exercise
Micra AV Exercise Testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18
  • Written informed consent
  • Presence of a Micra AV leadless pacemaker with the Micra AV 2.0 algorithm and at least 50% RV pacing
  • High grade atrioventricular heart block as the primary indication for permanent pacing
  • Sinus rhythm
  • Physical ability to walk on a treadmill or ride a recumbent bicycle for exercise testing

You may not qualify if:

  • Earlier version of the Micra leadless pacemaker
  • Intact atrioventricular conduction
  • Persistent atrial fibrillation
  • Those with absolute contraindications to exercise testing:
  • Acute myocardial infarction (MI) within 2 days
  • Ongoing unstable angina
  • Uncontrolled cardiac arrhythmia with hemodynamic compromise
  • Active endocarditis
  • Symptomatic severe aortic stenosis
  • Decompensated heart failure
  • Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis
  • Acute myocarditis or pericarditis
  • Acute aortic dissection
  • Physical disability that precludes safe and adequate testing
  • Inability to consent
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Atrioventricular Block

Condition Hierarchy (Ancestors)

Heart BlockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Camille Frazier-Mills

    Duke Medicine - Cardiology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2023

First Posted

July 28, 2023

Study Start

May 1, 2024

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)